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Medical Device

Heraeus, PALAMIX uno. Material Number: 66057893.

Recall date: 2026-05-06 · Source: FDA_DEVICE
Brand / Firm
Heraeus Medical GmbH (Dental Division)
Product
Heraeus, PALAMIX uno. Material Number: 66057893.
Reason for recall
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Units affected
51,771 units
Description
Heraeus, PALAMIX uno. Material Number: 66057893.
View official recall notice →